3% gel
diclofenac sodium 3% w/w
What Solaraze is and what it is used for
Solaraze is a non-steroidal anti-inflammatory dermatological gel. When applied to the skin, Solaraze gel is used to treat a skin condition called actinic keratosis, which is caused by prolonged exposure to the sun.
What you need to know before you use Solaraze
Do not use Solaraze
- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6)
- if you have had an allergic reaction such as skin rash ( hives ), breathing difficulties (wheezing and wheezing), or runny nose (allergic rhinitis) after taking aspirin or any other anti-inflammatory medicine.
- during the last three months of pregnancy.
Warnings and precautions
- The risk of systemic side effects when using Solaraze cannot be excluded if the product is used on large skin surfaces and for a longer period. Consult your doctor about:
- you have or have previously had a stomach ulcer or stomach bleeding,
- you have heart, liver, or kidney problems,
- if you have any type of bleeding disorder or bruise easily.
- Avoid direct sunlight, including tanning beds, when using Solaraze. Discontinue treatment if skin reactions occur.
- Do not apply to wounds, infected skin, or eczema.
- Do not allow Solaraze to come into contact with the eyes or the inside of the nose or mouth, and do not swallow it. If Solaraze is accidentally swallowed, see a doctor immediately.
- Stop treatment with Solaraze and contact your doctor if you develop a widespread skin rash.
- After using products containing diclofenac on the skin, you can use an air-permeable (non-occlusive) bandage. Do not use airtight occlusive bandages.
Pregnancy and breastfeeding
Talk to your doctor if you are or may be pregnant. Solaraze should be used with caution during the first six months of pregnancy but must not be used during the last three months of pregnancy.
Contact your doctor if you are breastfeeding. Solaraze can be used with caution during breastfeeding but should not be used on the breasts.
If you are pregnant, trying to become pregnant, or breastfeeding and your doctor thinks treatment is appropriate, Solaraze must not be applied to an area of skin larger than about one-third of your body and must not be used for longer than three weeks.
Ask your doctor or pharmacist for advice before taking any medicine.
Solaraze contains benzyl alcohol
This medicine contains 10 mg of benzyl alcohol per gram. Benzyl alcohol can cause allergic reactions and mild local irritation.
How to use Solaraze
- Solaraze is not suitable for children.
- Use gel one as directed by your doctor.
- Pierce the aluminum casing in the opening of the tube using the tip of the screw cap before use.
- Gently apply a small amount of gel to the skin area to be treated. The amount of gel needed varies depending on the size of the surface to be treated. Usually, 0.5 grams (the size of a pea) is sufficient for an area (5cm x 5cm), but more than 8 grams per day should not be used.
- You can apply Solaraze twice daily unless otherwise prescribed by your doctor. You can feel a slight cooling effect when the gel is rubbed into the skin.
- The usual processing time is 60-90 days. The maximum effect has been observed with treatment times closer to 90 days. Complete healing can take up to a month after treatment ends.
- Wash your hands after applying the gel, unless it is your hands that are being treated.
If you have used too much Solaraze
Remove excess gel by washing with water.
If you forget to use Solaraze
Continue to use as prescribed by the doctor but do not use a double amount to make up for a missed application.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop using Solaraze and contact your doctor as soon as possible:
skin rash ( hives ), difficulty breathing (wheezing and wheezing), swollen face; runny nose (allergic rhinitis). These symptoms suggest that you may be allergic to Solaraze.
If any of the following common side effects are severe or last more than a few days, stop using Solaraze and contact a doctor: Itching, rash, redness, inflammation, contact dermatitis, pain, and blisters.
Other common side effects: (may affect up to 1 in 10 people)
Irritation or stinging at the treatment site, conjunctivitis, allergy, pain when the skin is touched, tingling, muscle stiffness, skin inflammation, eczema, dry skin, swelling, rash (even scaly or with blisters), loose skin, and sores on the skin.
Uncommon side effects: (may affect up to 1 in 100 people)
Eye pain, watery/dry eyes, abdominal pain, diarrhea, nausea, hair loss, facial swelling, heavy bleeding, oily skin, and measles-like rash.
Rare: (may affect up to 1 in 1,000 users)
Dermatitis with large blisters
Very rare side effects: (may affect up to 1 in 10,000 users)
Stomach bleeding, kidney problems, breathing difficulties ( asthma ), infected skin rashes, and sensitivity to sunlight.
Temporary discoloration of hair at the application site has been reported. This usually reverses when treatment is stopped.
How to store Solaraze
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the tube or carton after ‘EXP’. The expiration date is the last day of the specified month.
Store at a maximum of 25ºC.
Shelf life after opening: 6 months
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is diclofenac sodium. One gram of gel contains the equivalent of 30 mg of diclofenac sodium.
- Other ingredients are sodium hyaluronate, benzyl alcohol, macrogol monomethyl ether 350, and purified water.
Appearance and package sizes of the medicine
Solaraze gel is a clear, transparent, colorless, or slightly yellow gel packaged in tubes containing 25 grams, 50 grams, 60 grams, 90 grams, or 100 grams.
Marketing Authorisation Holder
Almirall, SA; Ronda General Miter, 151; 08022 Barcelona; Spain
Manufacturer
Almirall Hermal GmbH, Scholtzstrasse 3, D-21465 Reinbek, Germany.